Economic Evaluation of Femtosecond Laser Assisted Cataract Surgery (FEMCAT)

October 2, 2018 updated by: University Hospital, Bordeaux

Impact Médico-Economique de la Chirurgie de la cATaracte au Laser Femtoseconde

Cataract is the leading cause of blindness worldwide and cataract surgery is the most frequent surgery performed in France. A new technology, the femtosecond laser-assisted cataract surgery, has to be compared with phacoemulsification alone, the conventional cataract surgery, to determine the economic impact of femtosecond laser-assisted process for the French healthcare insurance.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

An estimated 700,000 cataract procedures are performed every year in France, with this amount of surgeries predicted to climb as the population there, as well as around the world, ages. Currently, phacoemulsification alone is the conventional cataract surgery. The femtosecond laser-assisted cataract surgery has to be compared with the standard process to provide information on how it could benefit the patient population treated every year for cataract surgery. This economic study has received a grant from the French Ministry of Health to evaluate the economic impact of femtosecond laser-assisted process for the French healthcare system. For this goal, this prospective, randomized, parallel, multicenter and simple blind study will determine the incremental cost/effectiveness ratio for femtosecond laser-assisted process versus phacoemulsification surgery. Visual acuity results and intraoperative or postoperative complication rate will be compared between both groups. The learning curve of the femtosecond laser assisted cataract surgery will be also evaluated for each surgeon involved in the study.

Ethic and regulatory autority authorisations were obtained at 19/Dec/2012 and 15/Feb/2013, respectively. Date of first inclusion: 9/Oct/2013. Date of first NCT release: 13/Nov/2013. 30 patients were included between this period. French regulatory process dos not require NCT registration before first inclusion.

Study Type

Interventional

Enrollment (Actual)

920

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France, 33000
        • CHU de Bordeaux
      • Brest, France, 29609
        • CHU de Brest
      • Lyon, France, 69317
        • Hospices Civils de Lyon
      • Paris, France, 75679
        • Hôpital Cochin
      • Tours, France, 37044
        • Chu De Tours

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Cataract with impaired visual acuity (> or equal +0.3 LogMAR) or with cataract-related visual symptoms (Halos, Monocular diplopia, glare)
  • French healthcare insurance beneficiary

Exclusion Criteria:

  • Pupil size lower than 6mm
  • Iris constriction
  • Iris synechiae
  • Preoperative zonular instability or crystalline lens subluxation
  • Obstructive Corneal scars
  • Obstructive pterygion
  • Axial length <20.5 mm
  • Corneal astigmatism >1.5 diopters
  • Fuchs corneal dystrophy
  • History of Central retinal vein or artery occlusion
  • History of uveitis
  • History of optic nerve head neuropathy except glaucoma
  • Progressive glaucoma
  • Nystagmus
  • Uncontrolled diabetes mellitus
  • General history of dementia or psychotic disorders
  • Pregnancy, breast feeding
  • General medications: Alpha-blockers, Carbonic anhydrase inhibitors

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Phaco
Cataract surgery by phacoemulsification
Procedure: Cataract surgery with Phacoemulsification

Each patients randomized in the phaco arm will undergo a conventional cataract surgery.

Corneal incisions will be manually performed using the same calibrated blade and at the same location for all procedures of one surgeon.

Phacoemulsification machine used to perform cataract surgery in each center will be the same for all patients included in the center. The IOL (IntraOcular Lens) used in each center will be the same for all patients treated in the center.
Experimental: Femto
Corneal incision, anterior capsulorhexis and lens fragmentation by femtosecond laser
Device: Femtosecond laser-assisted cataract surgery

Each patients randomized in the femto arm will undergo a femtosecond laser assisted cataract surgery.

Corneal incisions will be performed by the laser. Number, size and location of the incisions must be the same than in the phaco arm for all patients treated by one surgeon.

Phacoemulsification machine used to remove the liquefied lens will be the same than in the phaco arm The IOL used in each center will be the same than in the phaco arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incremental Cost/effectiveness ratio defined as cost per incremental therapeutic success.
Time Frame: 3 months after inclusion

Therapeutic success will be defined by the association of the following criterion:

  • No severe intraoperative or postoperative complications,
  • Best Corrected Visual Acuity of 0 LogMAR,
  • A refractive error inferior or equal to 0.75 diopter,
  • Corneal surgically-induced astigmatism inferior or equal to 0.5 diopter and a postoperative change of astigmatism axis inferior or equal to 20°.
3 months after inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life
Time Frame: Before surgery (From day -8 to day -1) and months 1, 3 and 12 after surgery
Quality of life evaluation using Visual Function 14 questionnaire
Before surgery (From day -8 to day -1) and months 1, 3 and 12 after surgery
Learning curve of the femtosecond laser-assisted cataract surgery
Time Frame: End of research (Month 12)
End of research (Month 12)
Overall costs of cataract surgery in both arms from the hospital perspective
Time Frame: End of research (Month 12)
End of research (Month 12)
Incremental cost - Utility ratio defined as incremental Cost/QALY (Quality Adjusted Life Year) for healthcare insurance in both arms
Time Frame: 12 months after inclusion
12 months after inclusion
No severe intraoperative or postoperative complications
Time Frame: 3 months after inclusion
3 months after inclusion
Best Corrected Visual Acuity of 0 LogMAR
Time Frame: 3 months after inclusion
3 months after inclusion
Refractive error inferior or equal to 0.75 diopter
Time Frame: 3 months after inclusion
3 months after inclusion
Corneal surgically-induced astigmatism inferior or equal to 0.5 diopter and a postoperative change of astigmatism axis inferior or equal to 20°
Time Frame: 3 months after inclusion
3 months after inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bordeaux

Investigators

  • Principal Investigator: Cédric SCHWEITZER, MD, University Hospital Bordeaux, France
  • Study Chair: BENARD Antoine, MD, University Hospital Bordeaux, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 9, 2013

Primary Completion (Actual)

December 15, 2016

Study Completion (Actual)

December 15, 2016

Study Registration Dates

First Submitted

October 21, 2013

First Submitted That Met QC Criteria

November 5, 2013

First Posted (Estimate)

November 13, 2013

Study Record Updates

Last Update Posted (Actual)

October 4, 2018

Last Update Submitted That Met QC Criteria

October 2, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUBX 2012/23

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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